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Are SDS, IFRA and Allergen Sheets Enough for a CPSR?

This question was put to Eldris 46 times by 30 sellers between and .

SDS and IFRA sheets from a supplier, with an allergen sheet, are part of the file, not the whole of it. Under Article 10(1) of Regulation (EC) No 1223/2009, the Responsible Person must ensure a safety assessment before the product is placed on the EU market, and the CPSR is built from what you provide. Every raw material needs its own safety data sheet, and the formula and certificates of analysis are needed too.

With fragrance, the IFRA certificate, the allergen declaration and the fragrance level are needed. The per-formula fee is shown on the pricing page, and the CPSR and PIF are delivered 5–10 working days after complete documents.

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What do SDS and IFRA sheets cover?

Each sheet answers one start-list item. The SDS is the safety data sheet for one raw material, the IFRA certificate covers fragrance safety and the allergen declaration covers fragrance allergens.

Eldris asks for a safety data sheet for every raw material to start, so a formula needs one sheet for each material it uses. With fragrance, it also asks for the IFRA certificate, the allergen declaration and the fragrance level. A supplier set that holds an SDS for each material, an IFRA certificate and an allergen declaration therefore matches much of the supplier-side part of the list. Each sheet answers its own item, and none stands in for another. Fragrance products such as eau de parfum, eau de toilette, body mist and solid perfume are a cosmetic type Eldris assesses.

The allergen declaration matters twice. Eldris asks for it to start, and Commission Regulation (EU) 2023/1545 adds fragrance allergens to be declared on labels. Keep the supplier's allergen sheet with the formula. The full start list, including the documents that only help, is in the guide to documents needed to start a CPSR and PIF.

What does a supplier set leave out?

The set leaves out the formula, the fragrance level and the certificates of analysis, all needed to start, and every document that only helps.

ItemNeeded to startCovered by SDS, IFRA and allergen sheets
Safety data sheet (SDS)Yes, for every raw materialYes
IFRA certificate and allergen declarationYes, with fragranceYes
Fragrance levelYes, with fragranceNo
FormulaYesNo
Certificates of analysisYesNo
Product photosNot neededNo
GMP statementHelpsNo
Stability data and challenge testHelpsNo
An existing label designHelpsNo

A yes in the last column means that type of sheet covers the item, not that your particular sheet is complete. Use the table as a gap check: mark each row you can answer today, then, after you pay, upload what you have in your Eldris portal and Eldris tells you what is still missing. The rows marked Helps are not needed to start. Where those documents come from is covered in the next section.

Where do the missing items come from?

The formula and the fragrance level come from you; certificates of analysis come from ingredient suppliers, and the GMP statement comes from your manufacturer.

A bought-in base is part of the formula, so the ingredient list you give Eldris must account for it. The formula can be uploaded, or typed in as an ingredient list that adds up to the whole formula. The fragrance level describes your finished product, so it comes from your own formula and not from the fragrance supplier's sheets.

Certificates of analysis are needed to start, so ask each ingredient supplier for its own certificate along with its safety data sheet. Stability data and a challenge test come from a testing laboratory, which sets its own price. Eldris does not carry out, arrange or recommend laboratory tests. Your manufacturer, not an ingredient supplier, is the source of the GMP statement. Eldris writes your ingredient list in INCI names as part of the per-formula fee shown on the pricing page.

Checklist on a clipboard with a pen beside amber fragrance bottles and a laptop

How do supplier sheets feed the safety report?

Under Article 10(1) the safety assessment rests on the relevant information, and the CPSR is based on the formula, test data and documents you provide.

The CPSR has Part A, the safety information, and Part B, the safety assessment, as Annex I sets out. At Eldris, a qualified safety assessor signs the CPSR, Part A and Part B. The documents you provide, supplier sheets included, are what the assessor works from. They do not replace the formula or the assessment. A test report from your manufacturer or from a laboratory outside the EU goes to the safety assessor, who decides whether it is adequate for the EU file.

The test reports you supply go into the PIF, which the Responsible Person keeps for ten years after the last batch is placed on the market. In Great Britain the Responsible Person keeps a PIF in English that includes the product safety report, according to GOV.UK guidance. The CPSR and PIF service covers one formula per fee, whatever the number of ingredients, and the Responsible Person is a separate Eldris service.

What if one of the sheets is missing?

After you pay, upload what you have in your Eldris portal and Eldris tells you what is still missing. With fragrance, the IFRA certificate, the allergen declaration and the fragrance level are needed to start.

You can upload an incomplete set, and the missing items can follow. The 5–10 working days run from the day Eldris has your complete documents, so a missing item from the start list moves the start of the count. Which documents count as complete for your formula is something Eldris tells you after you upload.

A missing item from the helpful list does not stop the order from starting. A challenge test for a product that contains water is the same: you can start your order without it.

If the safety assessor needs a further sheet, the question appears in your portal, and the 5–10 working days start again from the day you answer. The clock restarts; it never pauses. The short answer is also in the FAQ hub: are SDS, IFRA and allergen sheets enough.

Frequently asked questions

Is the SDS of my finished product enough instead of one per raw material?

The start list asks for a safety data sheet for every raw material, so send the sheet for each material in the formula, whatever finished-product sheet you also hold. If the safety assessor needs more, the question appears in your portal, and the 5–10 working days start again from the day you answer.

What if I do not have the IFRA or allergen sheets for my perfumes?

With fragrance they are needed to start, together with the fragrance level. Your fragrance supplier is the place to ask for them, and the fragrance level comes from your own formula. After you pay, upload what you have in your Eldris portal and Eldris tells you what is still missing.

Do certificates of analysis have to come from the supplier?

Certificates of analysis come from your ingredient suppliers, and they are needed to start. Ask each ingredient supplier for its own certificate along with its safety data sheet. After you pay, upload what you have and Eldris tells you what is still missing.

Does the allergen declaration also matter for my label?

Commission Regulation (EU) 2023/1545 adds fragrance allergens to be declared on labels, and Eldris asks for the allergen declaration with fragrance to start. Article 19 of Regulation (EC) No 1223/2009 sets the wider labelling rules.

Who tells me what is missing from my set?

Eldris does, after you pay and upload what you have in your Eldris portal. Eldris does not carry out, arrange or recommend laboratory tests, so any test result you need comes from a testing laboratory, which sets its own price.

Does the clock start when I upload the supplier sheets?

No. The count starts when Eldris has your complete documents, not at the first upload. If the safety assessor needs more, the question appears in your portal, and the 5–10 working days start again from the day you answer.

Is a stability or challenge test part of the supplier set?

No. Stability data and a challenge test come from a testing laboratory, not from SDS, IFRA or allergen sheets. Eldris asks for a challenge test report (ISO 11930) for products that contain water, not water-free ones, but you can start your order without it.

Sources

  1. Regulation (EC) No 1223/2009 on cosmetic products (EUR-Lex)
  2. Cosmetic Products Notification Portal (CPNP), European Commission
  3. Commission Regulation (EU) 2023/1545 on the labelling of fragrance allergens (EUR-Lex)
  4. Making cosmetic products available to consumers in Great Britain, GOV.UK

From the Eldris channel

60-second answers

EC
Written by

Eldris Cosmetics

The Eldris Compliance Team prepares CPSR safety reports and PIF files for cosmetics brands selling in the EU, and writes these guides on Regulation (EC) No 1223/2009.

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Eldris prepares the Cosmetic Product Safety Report (CPSR) and the Product Information File (PIF) for each formula. A variation of an assessed formula (new shade or scent) is £39.95. When Eldris is your EU Responsible Person, Eldris also files the CPNP notification for £99 per CPSR.

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